INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

INITIAL RISK ASSESSMENT

FOR
RAPID MIXER GRANULATOR

Equipment Name Rapid Mixer Granulator

Equipment ID: TRMG-10

Manufacture Name Glatt®

Location Granulation - 1
Supersedes No.: 00
Effective Date:

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

TABLE OF CONTENTS

1. PREPARATION AND APPROVALS..............................................................................................3

2. REVISION HISTORY.......................................................................................................................4
3. OBJECTIVE.......................................................................................................................................5
4. SCOPE.................................................................................................................................................5
5. SYSTEM DESCRIPTION.................................................................................................................5
6. ROLE AND RESPONSIBILITY......................................................................................................6
7. REFERENCES...................................................................................................................................7
8. DOCUMENTATION MANAGEMENT..........................................................................................7
9. SYSTEM IMPACT ASSESSMENT.................................................................................................8
10. GAMP CATEGORIZATION OF CONTROL SYSTEM SOFTWARE & HARDWARE.........9
10.1 Software category............................................................................................................................9
10.2 Hardware category...........................................................................................................................9
11. ASSESSMENT SUMMARY...........................................................................................................10
12. ABBREVIATION.............................................................................................................................11

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

1. Preparation and Approvals

The signature listed below indicates the preparation and approval of this Document. Approval is joint
responsibility of listed functional areas.

M/s. Instrumentation and control solutions

Prepared By Name Designation Signature Date

Engineering
Services
Validation
Department

M/s. Abbott Healthcare Private Limited, Baddi

Reviewed By Name Designation Signature Date

User
Department

Engineering
Department

IT Department

Quality
Assurance
Department

Approved By Name Designation Signature Date

Quality
Assurance
Department

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

2. Revision History
Version / Revision Number Date Revised Reason for Revision

00 NA Initial Qualification

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

3. Objective
The objective of this document is to initial risk assessment for the PLC Based SCADA system of Rapid
Mixer Granulator (TRMG-10) for the following: GxP Assessment, GAMP categorization, and provide
the documented evidence. This will be the based document for the development of validation plan.
4. SCOPE
This initial risk assessment will be applicable on for the PLC Based SCADA system of Rapid Mixer
Granulator (TRMG-10) which is installed at M/s. Abbott Healthcare Private Limited.
5. SYSTEM DESCRIPTION

Equipment Name Rapid Mixer Granulator

Equipment ID TFBE-05

Location Granulation - 1

Manufacturer/Supplier Glatt®

A Rapid mixer granulator plays vital role to mix the ingredients and make granules before compression.
For wet granulation, choppers and impellers are mainly responsible in rapid granulator. This RMG
machine is also known in Industries with various key terms as High shear granulation machine, Dry
Powder granulator, Wet Granulator, Pharma Saizoner, High shear mixer granulator, high-shear
granulator, High Shear Mixer Granulators, Granulator, Wet Mixing, Rapid Mixer Granulator Machine,
Granulation Machine, and Rapid Mixer Granulator. Designed the impeller in such a way that full length
blades push the material and half-length blade lift the material. This impeller helps you to break the wet
mass into small pieces and granules. Chopper has very sharp small blades which are specially designed
to cut the wet lumps of material into very small parts which are then mixed by impellers. Discharge port
is used to unload the container filled with granules. It is located at the bottom of the dome. A hard M.S.
channel has been used to keep the drive assembly at the bottom. Stainless steel staircase and railings are
provided for the platform with a bowl mounted on the top. Half of the platform has been covered by S.S.
and dimpled Plates.

Page 5 of 11
 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

6. ROLE AND RESPONSIBILITY

The validation team comprising of representative from each of the following departments should be
responsible for overall compliance with this document.

Department Responsibilities

Validation Agency (ICS)  To prepare and submit IRA document for review and approval.

User Department (M/s. AHPL)  To review IRA document.

Engineering (M/s. AHPL)  To review IRA document.

QA (M/s. AHPL)  To review and approve IRA document.

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

7. REFERENCES
The publication listed below form part of this reference documents. Each publication shall have latest
revision in effect on the date of this document is approved for execution.
Documents/Guidelines Description/Version
GAMP 5 Good Automated Manufacturing Practices, Version 5, Guideline
Document for Automated Systems from International Society of
Pharmaceutical Engineering
21 Code of Federal Regulations Current Good Manufacturing Practice in Manufacturing,
(CFR), Part 210 Processing, Packing, or Holding off Drugs; General
21 Code of Federal Regulations
Current Good Manufacturing Practice for finished Pharmaceuticals
(CFR), Part 211
21 Code of Federal Regulations 21 Code of Federal Regulations (CFR), Part 11
(CFR), Part 11 Electronic Records, Electronic Signatures, Final Rule Electronic
Submissions; Establishment of Public Docket, Notice
ICH Q9 International Council of Harmonization (ICH) quality risk
assessment Q9
EU GMP Annexure 11 Laying down the principles and guidelines of GMP in respect of
medicinal products for human use.
FS Glatt® 18787-18788_FS_HSG, Version: 1.00
Operational Qualification 18787-18788_OQ_HSG, Version 1.00
Protocol
Computer system validation BDI-QA-GN-043 Version No.- 7.0
SOP

8. DOCUMENTATION MANAGEMENT
All quality and project relevant documents delivered by ICS are handled through M/s. Abbott Healthcare
Private Limited document management system.

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

9. SYSTEM IMPACT ASSESSMENT

The GxP assessment is carried based on a comprehensive understanding of system.
ID Question Yes No
1. Does the Computerized system impact the patient safety?
Does the Computerized system functionality create any hazards to the
2. environment including people working on the system such as process control
systems?
3. Does the system impact data about the quality of the product?
Is the system a process control system (e.g. PLC) that may affect product
4. quality and is there any independent verification of the control system
performance in place?
Is the computerized application/system the official auditable, archive or record
5.
of any regulated activity?
6. Is the computerized system used as part of the company's Quality System?
7. Is the computerized system used to control Quality System documentation?
8. Is the computerized system used to control Manufacturing documentation?
Is the computerized system used to control Verification and Validation
9.
documentation or data?
Is the computerized system used to control any packaging or labeling
10.
activities?
Is the computerized system used to maintain purchasing, inventory, or
11.
distribution data for the company's products?

12. Does the System implement any E-Signature?

13. Are there any Electronic Records associated with the system?

- Specified Field is selected

-Specified Field is not select
Conclusion: If any of above answer is Yes then the system belongs to GxP.

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

System Belongs To: - GxP Non GxP

If the system belongs GxP, Answer the below question. If not, validation of the system is not required.
However final decisions will be based on determinations from applicable Subject Matter and Technical
Experts, and as agreed upon by M/s. Abbott Healthcare Private Limited, Validation team and Quality
Assurance. The validation approach and deliverables will be determined by the project team in
consultation with QA.
10. GAMP CATEGORIZATION OF CONTROL SYSTEM SOFTWARE & HARDWARE

10.1 Software category

Category GAMP-5 Software Type Yes No

Infrastructure Infrastructure software including operating
1
Software systems, Database Managers, etc.
Non configured Non-configured Software e.g. Firmware based
3
Software application COTS software Instruments
Configurable Software Packages e.g.
DAS
SCADA
Configured
4 ERP
Software
DCS
BMS
LIMS
Custom Software e.g. internally or externally
developed IT applications.
5 Custom Software
Custom ladder logic
Spreadsheets (macro)

10.2 Hardware category

Category GAMP-5 Hardware Type Yes No

1 Hardware Category 1 Standard hardware component
2 Hardware Category 2 Custom built hardware component

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

11. Assessment Summary

Query Response

Is the Systems a GxP Impact System? Yes

What is the GAMP Category? 4
Do ER Apply? Yes
Do ES Apply? Yes

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 INITIAL RISK ASSESSMENT

M/s. Abbott Healthcare Private Limited , Baddi

Equipment Name: Rapid Mixer Granulator
Document No.: ICS-2102-310-V-02-IRA-R0 Equipment ID: TRMG-10

12. ABBREVIATION

Abbreviations Description

ICS Instrumentation and control solutions

AHPL Abbott Healthcare Private Limited

IRA Initial Risk Assessment

ID Identification

No. Number

QA Quality Assurance

IT Information Technology

NA Not Applicable

GAMP Good Automated Manufacturing Practices

Good ‘x’ Practice, where ‘x’ is one of: Clinical, Distribution, Laboratory, Manufacturing
GxP
or Engineering
CFR Code of Federal Regulations

cGMP Current Good Manufacturing Practice

ER/ES Electronic Records / Electronic Signatures

ICH International Council of Harmonization

EU European Union

PLC Programmable Logic Controller

SCADA Supervisory Control and Data Acquisition

FDA Food and Drug Administration

COTS Commercial off-the-shelf

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